Company ยท US
Cala Health, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QBC | External Upper Limb Tremor Stimulator | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2026 | K253587 | Cala kIQ Plus Cala Health, Inc. | QBC |
| Jan 16, 2025 | K243848 | Cala kIQ Cala Health, Inc. | QBC |
| Nov 22, 2024 | K242259 | Cala kIQ Cala Health, Inc. | QBC |
| Nov 22, 2022 | K222237 | Cala kIQ Cala Health, Inc. | QBC |
| Oct 5, 2021 | K203288 | Cala Trio Cala Health, Inc. | QBC |
| Oct 25, 2018 | K182706 | External upper limb tremor stimulator Cala Health, Inc. | QBC |
| Apr 26, 2018 | DEN170028 | Cala ONE Cala Health, Inc. | QBC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||